QUALITY SYSTEMSINDEX

Evidence for how production quality is controlled.

Testing and calibration laboratories internationally · international consensus standard used for laboratory accreditation

ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories

ISO/IEC 17025 sets competence, impartiality, and consistent-operation requirements for testing and calibration laboratories.

Published and current; confirmed in 2023Accreditation criteria when adopted by an accreditation body; not a generic software certification

What the authority record establishes

ISO/IEC 17025 sets competence, impartiality, and consistent-operation requirements for testing and calibration laboratories.

Accreditation criteria when adopted by an accreditation body; not a generic software certification

The exact official title, issuing body, jurisdiction, version or application record, and linked source define the scope of this page. Readers should not transfer the authority's status to a commercial product or infer transaction-, patient-, system-, site-, or organization-specific applicability from this summary.

Why it matters to this market

Industrial quality systems may exchange samples, methods, equipment, results, and certificates with laboratories, but the software record does not establish laboratory accreditation or competence.

Affected operating stages

  • Request And Sample
  • Method And Equipment
  • Test Or Calibration
  • Review And Authorization
  • Reporting
  • Record Retention

Capabilities to examine

Incoming, In-Process, And Final Inspection

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for incoming, in-process, and final inspection.

Calibration And Gage Management

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for calibration and gage management.

Controlled Documents And Workforce Qualification

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for controlled documents and workforce qualification.

Audit Planning And Findings

Ask how the system or service identifies the controlling source and version, applies customer-specific interpretation, handles exceptions, preserves human judgment, and retains evidence for audit planning and findings.

Affected buyer audiences

  • testing laboratories
  • calibration laboratories
  • metrology teams
  • laboratory accreditation owners

Implementation questions

  • Which entities, products, populations, transactions, systems, sites, or jurisdictions are actually within scope?
  • What is binding, what is guidance, and what is a technical or consensus standard?
  • Which publication, adoption, effective, application, transition, and enforcement dates differ?
  • Who owns legal, clinical, quality, regulatory, policy, or operational interpretation?
  • How will a source revision affect open work and historical decisions?

Interpretation boundary

The publication does not infer ISO/IEC 17025 accreditation from a laboratory-software or calibration feature claim.